A Dec. 11 amendment to the PREP Act has sparked debate over accountability for COVID-19 vaccine-related injuries.
The Biden administration has extended liability protections for COVID-19 vaccine makers, health care providers, and others through 2029. The decision, which has sparked renewed debate over accountability for vaccine-related injuries and the future of public health policy, ensures immunity from most lawsuits for those involved in the development and distribution of COVID-19 vaccines and other medical countermeasures.
The five-year extension, signed by Health and Human Services (HHS) Secretary Xavier Becerra on Dec. 11, continues a policy first implemented during the pandemic under then-President Donald Trump. It is one of the longest liability protections in the history of the Public Readiness and Emergency Preparedness (PREP) Act. Proponents argue that the protections are essential for fostering innovation and maintaining public health readiness, but critics contend they leave vaccine-injured individuals without recourse and could limit future administrations’ ability to enact significant policy changes.
While the official COVID-19 public health emergency ended on May 11, 2023, the new declaration warns of a “credible risk of a future public health emergency.”
The PREP Act, enacted in 2005, grants liability immunity to encourage the swift development and deployment of medical countermeasures during public health emergencies. Without this protection, manufacturers and providers might hesitate to produce or distribute critical products—like vaccines or treatments—due to fears of lawsuits over unforeseen side effects. The act was first invoked for COVID-19 in March 2020, covering vaccines, antiviral treatments, diagnostic tools, and protective equipment.
As the United States prepares for potential future outbreaks, this latest extension ensures that legal protections for manufacturers and health care providers remain intact. However, the decision has sparked fresh calls for reform—or even repeal—of the PREP Act, with critics pushing for greater accountability and support for individuals harmed by medical countermeasures.
Broadening Scope of the PREP Act
Amendments to the PREP Act during the pandemic expanded its scope to include telehealth providers and pharmacy technicians, thus speeding up the rollout of vaccines in response to urgent health needs. According to the American Pharmacists Association, these changes improved access in underserved communities, where local pharmacies often serve as primary health care providers. Nearly 90 percent of Americans live within five miles of a pharmacy. Previous amendments also supported health care providers in non-traditional settings, reflecting the shifting demands of public health emergencies.
By Sheramy Tsai
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